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Cmc Jobs (NOW HIRING)

Staffingine LLC

CMC Writer

Paramus, NJ · On-site

CMC Writer Job Location: Paramus, NJ Job Type: Contract * Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents ...

Staffingine LLC

CMC Writer

Paramus, NJ · On-site

CMC Writer Job Location: Paramus, NJ Job Type: Contract * Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables ...

Watton Hall

CMC Specialist

CMC Specialist The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory submissions for pharmaceutical products.

Atomic

CMC Consultant

Indomo is seeking an experienced CMC consultant to execute Chemistry, Manufacturing & Controls (CMC) strategy and operations on a fractional basis. This individual will play a critical role in ...

TekWissen LLC

CMC Writer

Paramus, NJ · On-site

$45 - $50/hr

CMC Writer Location: Paramus, New Jersey, 07652 Job Type: Contract Duration: 6 Months Work Type: Hybrid * A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in ...

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · Hybrid

Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview This position will support the development and execution of global CMC ...

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

Scope covers CMC strategy, cell line and process development, analytical development and characterization, formulation, external manufacturing and supply, and the CMC sections of regulatory ...

Rhythm Pharmaceuticals

Director, Regulatory CMC

Boston, MA · On-site

$182K - $275K/yr

This individual contributor role will execute regulatory CMC plans and support implementation of filing strategies for assigned programs. As part of the growing and dynamic regulatory affairs team ...

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

$300 - $380/hr

Position Reporting to the EVP of R&D, the Head of CMC owns the technical strategy and the hands-on execution that carries our molecules from research-grade material to GMP clinical supply and all ...

Korsana Biosciences, Inc.

VP, CMC

Waltham, MA · On-site

$300 - $340/hr

VP, CMC Korsana Biosciences, Inc. Waltham, Massachusetts, United States About this positionAbout Us Korsana Biosciences is a private biopharmaceutical company advancing a pipeline of potential best ...

Immunedge Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

Reporting to the EVP of R&D, the Head of CMC owns the technical strategy and the hands-on execution that carries our molecules from research-grade material to GMP clinical supply and all related ...

Us tech Solutions

CMC Regulatory Manager

Morristown, NJ · On-site

CMC Manager Duration: 12 Months Location: Morristown, NJ 07962 The CMC Documentation Team is responsible for the development of Chemistry, Manufacturing and Control (Module 3) documentation for the ...

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CMC information

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$13

$31

$67

How much do cmc jobs pay per hour?

As of Aug 28, 2026, the average hourly pay for cmc in the United States is $31.24, according to ZipRecruiter salary data. Most workers in this role earn between $19.23 and $36.54 per hour, depending on experience, location, and employer.

What is a CMC?

CMC stands for Chemistry, Manufacturing, and Controls. CMC professionals are responsible for ensuring that pharmaceutical products are developed, manufactured, and controlled in compliance with regulatory standards. Their work includes overseeing formulation development, analytical testing, process validation, and documentation required for regulatory submissions. CMC experts play a critical role in bringing safe and effective drugs to market by ensuring product quality and consistency throughout the development and manufacturing process.

What are some common challenges faced by a CMC professional when coordinating between R&D, manufacturing, and regulatory teams?

CMC professionals often encounter challenges in aligning the timelines and priorities of R&D, manufacturing, and regulatory teams. Ensuring that product development meets both regulatory requirements and manufacturing feasibility can require extensive cross-functional communication and problem-solving. Additionally, adapting to evolving regulatory guidelines and integrating feedback from multiple stakeholders demands strong project management skills. Overcoming these challenges is essential for maintaining project momentum and ensuring successful product submissions.

What are the key skills and qualifications needed to thrive as a CMC professional, and why are they important?

To thrive as a CMC professional, you need expertise in pharmaceutical sciences, regulatory requirements, and process development, typically supported by a degree in chemistry, pharmacy, or a related field. Familiarity with regulatory submission systems, analytical tools, and quality management software is essential. Strong project management, attention to detail, and effective communication are vital soft skills for coordinating cross-functional teams and ensuring compliance. These skills and qualities are critical to guarantee the safety, efficacy, and regulatory approval of pharmaceutical products.

What is the difference between CMC vs Regulatory Affairs Specialist?

AspectCMCRegulatory Affairs Specialist
Required CredentialsBachelor's degree in life sciences, chemistry, or pharmacy; often additional certifications in pharmaceutical sciencesBachelor's degree in life sciences, pharmacy, or related field; certifications in regulatory affairs are common
Work EnvironmentLaboratories, manufacturing sites, and R&D departments within pharmaceutical companiesRegulatory agencies, pharmaceutical companies, and consulting firms
Industry UsageFocuses on drug development, manufacturing, and quality documentationFocuses on compliance, submissions, and communication with regulatory bodies

While both CMC and Regulatory Affairs Specialists work within the pharmaceutical industry, CMC professionals primarily handle the chemistry, manufacturing, and control aspects of drug development. Regulatory Affairs Specialists focus on ensuring compliance with regulations and managing submissions to authorities. Both roles often collaborate but serve distinct functions in bringing a drug to market.

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CMC jobs near you
Infographic showing various Cmc job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 76% Full Time, 19% Part Time, and 4% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $64,986 per year, or $31.2 per hour.

CMC Writer

Staffingine LLC

Paramus, NJ • On-site

Contractor

Re-posted 13 days ago

Job description

Job Title: CMC Writer
Job Location: Paramus, NJ
Job Type: Contract

Job Description:

  • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
  • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions
  • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions
  • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines.
  • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions.
  • Assess and communicate potential regulatory risks and propose mitigation strategies
  • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications.
  • Identify, communicate and escalate potential CMC regulatory issues, as needed
  • Help establish regulatory CMC submission processes and procedures.
  • Familiar with eCTD format submission files
  • Project management skill is plus
  • Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.
  • Ensure documents align with FDA, EMA, and ICH regulatory requirements.
  • Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.
  • Maintain consistency, clarity, and accuracy in technical writing.
  • Help establish regulatory CMC submission processes and procedures.